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Federal Circuit extends safe harbor to post-approval activities

August 13, 2012

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On August 3, 2012, the Federal Circuit issued a decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. extending the scope of the "safe harbor" under 35 U.S.C. § 271(e)(1) to certain post-FDA approval activities. Typically, the safe harbor is a limited time period during which drug development activities for the purpose of obtaining FDA approval are exempt from charges of patent infringement, and thus the safe harbor usually would end upon obtaining FDA approval. Both Momenta and Amphastar commercially market generic versions of enoxaparin. At issue in Momenta was Amphastar’s alleged infringement of Momenta’s patented method for testing the purity and strength of enoxaparin, by using quality control processes that were required to be carried out for each commercial batch of enoxaparin. The Federal Circuit held that these post-approval activities, which were essential to Amphastar’s ability "to continue manufacturing and marketing enoxaparin," were exempt under the safe harbor because they generated information for submission to the FDA. One judge of the three-judge panel dissented, arguing that the majority holding "will render worthless manufacturing test method patents." The Momenta decision arguably conflicts with an earlier Federal Circuit decision, Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), which suggested that the safe harbor ends upon FDA approval. We may gain further clarity on this question from either the Federal Circuit, if it grantsen banc rehearing in Momenta, or from the Supreme Court, if it grants the pending petition for certiorari inClassen.

In the Momenta opinion authored by Judge Moore and joined by Judge Dyk, the court held that "post-approval studies that are ‘reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs’ fall within the scope of the § 271(e)(1) safe harbor." The patents at issue claimed methods for testing the purity and strength of the enoxaparin, which are necessary for quality control of each commercial batch of enoxaparin sold. In the earlier ruling last August in Classen, the Court appeared to rule that the safe harbor ends upon FDA approval. According to Classen, "the statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." Id. at 1070. In Classen, the patentee asserted infringement of patents claiming methods of administering immunizations and selecting an immunization schedule. The Federal Circuit ruled that the safe harbor did not apply regardless of whether these methods were used to collect post-approval information submitted to the FDA. Id. at 1071-72.

The court in Momenta, however, interpreted Classen narrowly, explaining that its holding is limited to information "routinely reported" to the FDA "long after marketing approval." In contrast, the court characterized Amphastar’s FDA submissions as "anything but ‘routine,’" and essential to Amphastar’s ability "to continue manufacturing and marketing enoxaparin under its ANDA." Writing a vigorous dissenting opinion, Chief Judge Rader relied extensively on the legislative history of § 271(e)(1) to argue that the court should have followed the Classendecision and held that the safe harbor does not apply to post approval activities. Judge Newman wrote the decision in Classen, in which Chief Judge Rader joined and from which Judge Moore dissented.

At this juncture, the decisions in Classen and Momenta are difficult to reconcile, and the outcome of future cases is impossible to predict. Is there a bright-line end to the safe harbor upon approval? The Supreme Court has called for the views of the Solicitor General in Classen, suggesting that the Court may grant certiorari if the Solicitor General recommends that it do so. Or the Federal Circuit may grant en banc rehearing in Momenta.